New Tools for Generic Orally Inhaled Drug Products to Maximize Prospects of Food and Drug Administration Approval
Lionberger RA.
Respiratory Drug Delivery 2018. Volume 1, 2018: 221-230.
Abstract:
The two user fee agreements related to generic drugs in the USA, Generic Drug User Fee Acts (GDUFA) I and II, have transformed the landscape for development of generic inhalation products. GDUFA I enabled an order of magnitude increase in Food and Drug Administration (FDA) supported research related to generic drugs and a surge of product specific guidance (PSG) related to oral inhalation drug products (OIDP). Before GDUFA I (September 2012) there was no PSG related to inhalation products. In September 2017, there were 17 individual guidances available. GDUFA II, which began on October 1 2017, added a significant new pre-application aspect to generic drug development in pre-abbreviated new drug application (ANDA) meetings with FDA, where companies were able to discuss new or alternative development strategies for complex generic drug products. The major changes in approach are summarized in this paper.
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